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Miacalcin Nasal (Calcitonin (Salmon) Nasal) - Summary



Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish.

Miacalcin® (calcitonin-salmon) Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. Miacalcin® Nasal Spray should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Use of Miacalcin® (calcitonin-salmon) Nasal Spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (400 I.U. per day) intake to retard the progressive loss of bone mass. The evidence of efficacy is based on increases in spinal bone mineral density observed in clinical trials.
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Published Studies Related to Miacalcin Nasal (Calcitonin Nasal)

Efficacy and harms of nasal calcitonin in improving bone density in young patients with inflammatory bowel disease: a randomized, placebo-controlled, double-blind trial. [2011.08]
OBJECTIVES: There are very few published studies of agents having the potential to improve bone health in children with inflammatory bowel disease (IBD). The objective of this study was to establish the efficacy and safety of intranasal calcitonin in improving bone mineral density (BMD) in young patients with IBD and to define additional factors that impact bone mineral accrual... CONCLUSIONS: Intranasal calcitonin is well tolerated but does not offer a long-term advantage in youth with IBD and decreased BMD. Bone mineral accrual rate remains compromised in youth with IBD and low BMD raising concerns for long-term bone health outcomes. Improvement in nutritional status, catch-up linear growth, control of inflammation, increase in weight-bearing activity, and lower daily caffeine intake may be helpful in restoring bone density in children with IBD and low BMD.

Optimizing bioavailability of oral administration of small peptides through pharmacokinetic and pharmacodynamic parameters: the effect of water and timing of meal intake on oral delivery of Salmon Calcitonin. [2008.09.09]
BACKGROUND: To investigate the influence of water intake and dose timing on the pharmacokinetic and pharmacodynamic parameters of an oral formulation of salmon calcitonin (sCT)... CONCLUSION: 0.8 mg sCT with 50 ml of water taken 30 and 60 minutes prior to meal time resulted in optimal pharmacodynamic and pharmacokinetic parameters. The data suggest that this novel oral formulation may have improved absorption and reduction of bone resorption compared to that of the nasal form.

A randomized double-blind placebo-controlled trial to investigate the effects of nasal calcitonin on bone microarchitecture measured by high-resolution peripheral quantitative computerized tomography in postmenopausal women - Study protocol. [2008.04.13]
ABSTRACT: BACKGROUND: Bone microarchitecture is a significant determinant of bone strength.We hypothezise that - compared to placebo - calcitonin impacts on microstructural parameters, with a possible difference between weight bearing and non-weight bearing bones.

Comparison of calcitonin versus calcitonin + resistance exercise as prophylaxis for osteoporosis in heart transplant recipients. [2006.04.27]
BACKGROUND: Rapid bone loss occurs early after heart transplantation. There is no standard therapeutic intervention to prevent osteoporosis in heart transplant recipients (HTR). The purpose of this study was to determine the effectiveness of a regimen combining the antiresorptive properties of nasal calcitonin with the osteogenic stimulus of resistance exercise... CONCLUSIONS: Calcitonin attenuates BMD loss in the total body and femur neck but not in trabecular bone of the lumbar vertebra. Mechanical loading, through progressive resistance exercise, is an osteogenic stimulus in HTR.

The effectiveness of calcitonin on chronic back pain and daily activities in postmenopausal women with osteoporosis. [2006.03]
The aim of this study was to investigate the effect of nasal calcitonin on chronic back pain and disability attributed to osteoporosis. The study design involved three groups of osteoporotic postmenopausal women suffering from chronic back pain... Intranasal calcitonin has no effect on chronic back pain intensity and functional capacity of osteoporotic women regardless of the presence of fractures, degenerative disorders or chronic back pain of non-specific etiology.

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Clinical Trials Related to Miacalcin Nasal (Calcitonin Nasal)

A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women [Completed]
The purpose of this study is to compare the effectiveness and tolerability of two medications, calcitonin nasal spray and a tablet containing calcitonin, in postmenopausal women with osteoporosis. Osteoporosis is the term used to describe a large group of diseases, which are characterized by loss of bone density, which makes the bones weaker. Osteoporosis often occurs in postmenopausal women. Calcitonin is a hormone found in the human body. Together with other substances, it regulates the concentration of calcium in the blood and inhibits the natural resorption of bone. Both medications in this study contain salmon calcitonin (sCT), because this form of calcitonin is more active than human calcitonin when used as a medicine. The calcitonin Nasal Spray used in this study is registered and available to doctors in United States for the treatment of osteoporosis. The medication being tested in this study is an oral tablet form of salmon calcitonin.

Calcitonin for Treating X-linked Hypophosphatemia [Recruiting]
X-linked hypophosphatemia (XLH) is the most common form of inherited rickets in the United States. It also causes bone disease in adults. XLH is caused by overproduction of a hormone call FGF23, which makes the body waste phosphate. This study is designed to determine if nasal calcitonin, an already approved drug in the US, can lower blood levels of FGF23 and reduce phosphate wasting in patients with XLH. In this study the investigators will: 1. Determine whether nasal calcitonin significantly lowers integrated 24-hour blood levels of FGF23 in patients with XLH. 2. Evaluate whether nasal calcitonin improves serum phosphate levels in XLH. 3. Assess whether nasal calcitonin improves blood levels of the active form of vitamin D and calcium absorption from the intestine. 4. Make sure that nasal calcitonin is safe and well tolerated.

A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis [Completed]
The primary purpose of this study was to evaluate the efficacy of oral calcitonin (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral density at increased risk of fracture. The secondary purpose of this study was to determine if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets administered at dinner or at bedtime.

Calcitonin in the Treatment of Fibromyalgia [Enrolling by invitation]
The purpose of this study is to determine whether nasal administration of salmon calcitonin is effective and safe in the treatment of symptoms and signs of primary fibromyalgia.

FGF-23 Suppressibility by Calcitonin [Recruiting]
Introduction: Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important regulator of FGF-23 production and secretion in healthy humans. Aim: In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men. Study Design: placebo-controlled, cross-over study Method:

- All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml

NaCl 0. 9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously

- On both occasions frequent bloodsampling will take place, out an indwelling catheter in

de forearm vein.

- Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes

- Mealtimes: Calcium and Phosphate intake standardized on both occasions

- All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics,

San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that measures only intact FGF-23

- Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca,

albumin, PO4, PTH, 25-OHD and 1,25-OHD Endpoint: A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.

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Page last updated: 2011-12-09

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